Regulatory Significance 7/10

Systematic Review Delivers Updated Biological Variation Estimates for 20 Haematology Parameters

Applying the Biological Variation Data Critical Appraisal Checklist to 32 studies, this systematic review and meta-analysis produced quality-graded within-subject and between-subject biological variation estimates for complete blood count parameters. The resulting values were generally lower than those in the historical BV database, with erythrocyte-related CVI below 3% and leukocyte/platelet CVI ranging 5-15%. These updated estimates have been incorporated into the EFLM Biological Variation Database for use in analytical performance specifications.

The original study

Systematic review and meta-analysis of within-subject and between-subject biological variation estimates of 20 haematological parameters.

Authors
Coskun A, Braga F, Carobene A, Tejedor Ganduxe X, Aarsand AK, Fernández-Calle P, et al.
Journal
Clinical chemistry and laboratory medicine
Type
Journal Article, Meta-Analysis, Systematic Review
PMID
31503541
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Original abstract

Background Interpretation of the complete blood count (CBC) parameters requires reliable biological variation (BV) data. The aims of this study were to appraise the quality of publications reporting BV data for CBC parameters by applying the BV Data Critical Appraisal Checklist (BIVAC) and to deliver global BV estimates based on BIVAC compliant studies. Methods Relevant publications were identified by a systematic literature search and evaluated for their compliance with the 14 BIVAC criteria, scored as A, B, C or D, indicating decreasing compliance. Global CVI and CVG estimates with 95% CI were delivered by a meta-analysis approach using data from BIVAC compliant papers (grades A-C). Results In total, 32 studies were identified; four received a BIVAC grade A, 2 B, 20 C and 6 D. Meta-analysis derived CVI and CVG estimates were generally lower or in line with those published in a historical BV database available online. Except for reticulocytes, CVI estimates of erythrocyte related parameters were below 3%, whereas platelet (except MPV and PDW) and leukocyte related parameters ranged from 5% to 15%. Conclusions A systematic review of CBC parameters has provided updated, global estimates of CVI and CVG that will be included in the newly published European Federation of Clinical Chemistry and Laboratory Medicine BV Database.